Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT03946969
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C079198', 'term': 'S 1 (combination)'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcomes', 'timeFrame': '20 months', 'description': 'Correlation between biomarkers, including tumor mutational burden (TMB), clonal mutations, genetic alterations, and circulating tumor DNA (ctDNA), and therapeutic response to neoadjuvant therapy will be explored.'}], 'primaryOutcomes': [{'measure': 'Safety and feasibility', 'timeFrame': '20 months', 'description': 'Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.'}], 'secondaryOutcomes': [{'measure': 'MPR rate', 'timeFrame': '20 months', 'description': 'Major Pathological Response (MPR) is defined as the presence of 10% or fewer viable cancer cells in the hematoxylin and eosin (H\\&E)-stained slides from the resected tumor following neoadjuvant treatment.'}, {'measure': 'R0 resection rate', 'timeFrame': '20 months', 'description': 'R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.'}, {'measure': 'Recurrence-Free Survival (RFS)', 'timeFrame': '5 years', 'description': 'Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant', 'Esophageal Cancer', 'PD-1'], 'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36759013', 'type': 'DERIVED', 'citation': 'Chen X, Xu X, Wang D, Liu J, Sun J, Lu M, Wang R, Hui B, Li X, Zhou C, Wang M, Qiu T, Cui S, Sun N, Li Y, Wang F, Liu C, Shao Y, Luo J, Gu Y. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial. J Immunother Cancer. 2023 Feb;11(2):e005830. doi: 10.1136/jitc-2022-005830.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.', 'detailedDescription': 'This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically or cytologically confirmed esophageal squamous cell carcinoma.\n\nThe tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).\n\nNo prior treatment for this disease.\n\nEastern cooperative oncology group (ECOG) performance status of 0 to 1.\n\nAdequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.\n\nUnderstand and voluntarily sign the informed consent(s).\n\nPatients who are able to complete the treatment and follow-up according to the study plan.\n\nPatients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.\n\nFemale patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\nPatients who may develop tracheoesophageal fistula or aortoesophageal fistula.\n\nPatients suffering from severe malnutrition or needing tube feeding.\n\nUncured patients with other malignancies within 2 years.\n\nPatients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.\n\nPatients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.\n\nPatients who have immune deficiency.\n\nPatients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.\n\nPatients with uncontrolled diabetes mellitus.\n\nPatients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.\n\nPatients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .\n\nPatients who have received allogeneic organ or stem cell transplants.\n\nPatients who are allergic to drugs or related ingredients in this study.\n\nPatients who take part in clinical trials of other drugs or biological therapy at present.\n\nPatients with any serious or unstable medical condition or mental illness.\n\nPatients who are dependent on or addicted to alcohol or drugs.'}, 'identificationModule': {'nctId': 'NCT03946969', 'briefTitle': 'Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study', 'orgStudyIdInfo': {'id': 'KEEP-G 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1', 'description': 'Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.', 'interventionNames': ['Drug: Sintilimab', 'Drug: Liposomal Paclitaxel + Cisplatin + S-1']}], 'interventions': [{'name': 'Sintilimab', 'type': 'DRUG', 'otherNames': ['IBI308'], 'description': 'Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for two cycles.', 'armGroupLabels': ['Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1']}, {'name': 'Liposomal Paclitaxel + Cisplatin + S-1', 'type': 'DRUG', 'otherNames': ['PFC'], 'description': 'Liposomal Paclitaxel (135mg/m2), ivd, d1 + Cisplatin (25mg/m2), ivd, d1-3 + S-1 capsule (40mg), po, d1-14, repeated every 3 weeks for two cycles.', 'armGroupLabels': ['Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Yanhong Gu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Gu Yanhong', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}